Protocol Administration Set with Small Catheter and Retention Cuff 390402

GUDID 30815112021284

Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation

BRACCO DIAGNOSTICS INC

Insufflation gas conditioning tubing set
Primary Device ID30815112021284
NIH Device Record Key3993f4cd-4f02-47d1-8d14-53ee9d541862
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtocol Administration Set with Small Catheter and Retention Cuff
Version Model Number390402
Catalog Number390402
Company DUNS849234661
Company NameBRACCO DIAGNOSTICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx

Device Dimensions

Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French
Catheter Gauge20 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021280 [Primary]
GS130815112021284 [Package]
Contains: 10815112021280
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-07
Device Publish Date2023-06-29

On-Brand Devices [Protocol Administration Set with Small Catheter and Retention Cuff]

30815112020171Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon
30815112021284Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon

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